MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY COMBO HOOK BLADE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SNGHK2
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during a coronary artery bypass graft, the tip of the device broke off and fell into the patient.It was noted that "it might have came in contact with a metal pick up device." the broken piece was found and removed form the patient and the procedure was completed with an alternate like device with no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/11/2020.D4: batch # n9058h.Investigation summary the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, and had evidence of contact with metal in or out of the operative field.During functional testing on gen11 an alert screen was displayed.A probable cause for the device to stop activating and to display an alert screen is blade damage.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, contact with staples or clips during the procedure, or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activation may increase the severity of the blade damage.This, in turn, can result in the device failing the pre-run test with the generator and displaying an alert screen.The alert screens that can result may include ¿tighten assembly,¿ ¿blade error detected,¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: HS SYNERGY COMBO HOOK BLADE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9695839
• Report Number: 3005075853-2020-00946
• Device Sequence Number: 13616531
• Product Code: LFL
• UDI-Device Identifier: 10705036013815
• UDI-Public: 10705036013815
• Combination Product (Y/N): N
• PMA/510(K) Number: SNGHK2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: SNGHK2
• Device Catalogue Number: SNGHK2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE